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Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma

Primary Purpose

Advanced Glaucoma, Refractory Glaucoma

Status

Unknown status

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Micropulse Transscleral Cyclophotocoagulation

Conventional Transscleral Cyclophotocoagulation

About this trial

This is an interventional treatment trial for Advanced Glaucoma focused on measuring Advanced glaucoma, Refractory glaucoma, Cyclophotocoagulation, Transscleral cyclophotocoagulation, Micropulse transscleral cyclophotocoagulation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: · More than 21 years old Advanced glaucoma refractory to maximum tolerated medical and surgical treatment Visual acuity worse than 6/60 Poor candidates for additional filtration surgery Exclusion Criteria: · Any eye surgery done within 2 months of enrolment Any ocular infection or inflammation Unable to give informed consent

Sites / Locations

National University Hospital Singapore Department of OphthalmologyRecruiting

Outcomes

Primary Outcome Measures

Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months

Secondary Outcome Measures

Number of patients with complications, such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage

Full Information

NCT ID

NCT00349414

First Posted

July 6, 2006

Last Updated

May 13, 2008

Sponsor

National University Hospital, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT00349414

Brief Title

Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma

Official Title

A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National University Hospital, Singapore

4. Oversight

5. Study Description

Brief Summary

The aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma.

Detailed Description

End-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. A common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. This study specifically aims to compare the intraocular pressure (IOP) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.The hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Glaucoma, Refractory Glaucoma

Keywords

Advanced glaucoma, Refractory glaucoma, Cyclophotocoagulation, Transscleral cyclophotocoagulation, Micropulse transscleral cyclophotocoagulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Micropulse Transscleral Cyclophotocoagulation

Intervention Type

Procedure

Intervention Name(s)

Conventional Transscleral Cyclophotocoagulation

Primary Outcome Measure Information:

Title

Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Tan, MMed

Phone

6772-5317

amwttan@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Grace Dizon, MD

Phone

6772-5317

gengmd@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Chew, FRCSEd,MMed

Organizational Affiliation

National University Hospital,Ophthalmology Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital Singapore Department of Ophthalmology

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Tan, MMEd

First Name & Middle Initial & Last Name & Degree

Grace Dizon, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

9142680

Citation

Berger JW. Thermal modelling of micropulsed diode laser retinal photocoagulation. Lasers Surg Med. 1997;20(4):409-15. doi: 10.1002/(sici)1096-9101(1997)20:43.0.co;2-u.

Results Reference

background

PubMed Identifier

12213158

Citation

Ho CL, Wong EY, Chew PT. Effect of diode laser contact transscleral pars plana photocoagulation on intraocular pressure in glaucoma. Clin Exp Ophthalmol. 2002 Oct;30(5):343-7. doi: 10.1046/j.1442-9071.2002.00553.x.

Results Reference

background

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Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma

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